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Spirit® Hydrocolloid Adhesive Sheath 37305Recalls & reported problems

C. R. Bard, Inc. · Spirit® Hydrocolloid Adhesive Sheath · Class 1

All models of Spirit Hydrocolloid Adhesive Sheath (28)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741071218), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Damaged Prior to Use1
  • Difficult to Insert1
  • Scratched Material1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2019Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use; Scratched Material

    IT WAS REPORTED THAT THE CATHETERS WERE SCRATCHY AND CAUSED THE PATIENT PAIN DURING THE INSERTION OF THE CATHETER. THE PATIENT COULD NOT FULLY INSERT THE CATHETERS FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: Pain

    MAUDE report 8691849 ↗

Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices

All DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices →

Sources and updates

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